Note: Numerous studies in the available literature have examined the effects of mixed-ingredient lycopene interventions, including Lyc-O-Mato® and LycoRed® (both manufactured by LycoRed Natural Products Industries Ltd., Beer-Sheva, Israel). According to the manufacturer's website, LycoRed® and Lyc-O-Mato® are lycopene-rich supplements also containing various other phytonutrients typically found in whole tomatoes, including tocopherols, phytoene, phytofluene, and beta-carotene. Though the effects of oral lycopene supplementation alone may be unclear from research focusing on mixed-ingredient products, information regarding the safety and efficacy of select combination products is still included in this patient monograph.

Lycopene is a bright red pigment that is naturally found in the human liver, blood, adrenal glands, lungs, prostate, colon, and skin at higher levels than other similar pigments. In animal studies, lycopene has been found to have antioxidant effects and may also block cancer cell growth. However, there is still controversy over whether it has these effects in humans.

Many studies suggest that eating lycopene-rich foods or having high lycopene levels in the body may be linked to reduced risk of cancer, heart disease, and age-related eye disorders. However, measures of lycopene intake have been based on eating tomatoes, not on the use of lycopene supplements. Since tomatoes also contain other nutrients, such as vitamin C and potassium, the potential benefits of lycopene alone are still unclear.

Lycopene deficiency is not considered a medical condition. There is a lack of evidence on whether increasing low lycopene levels may benefit health.

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

GRADE *

Although lycopene is believed to have antioxidant benefits, research has found mixed results in this area. Research has looked at lycopene levels in the body or focused on tomatoes or tomato-based products, rather than on lycopene supplements. Limited studies on lycopene supplements with other ingredients suggest antioxidant benefits. More information is needed on the potential effects of lycopene alone.

C

Research suggests that lycopene may have antioxidant benefits. These effects are believed to help prevent asthma caused by exercise, although the method is still unclear. Early studies also report that tomato-rich diets may benefit people with asthma. However, available research has used products and supplements with mixed ingredients. More research is needed to better understand the potential effect of lycopene alone.

C

Although not well studied in humans, early research suggests that lycopene may act as a blood thinner. Most available research in humans has been limited to the use of tomato extract. More research is needed to determine the effects of lycopene alone.

C

There is limited research on the use of lycopene together with chemotherapy for brain tumors. Early research suggests that this combination lacks benefit over chemotherapy alone. More information is needed on the use of lycopene in people with brain tumors.

C

Lycopene and lycopene-rich foods have been studied as a potential therapy for breast cancer. Early studies on breast cancer have looked for a possible link between disease risk and fruit or vegetable intake, tomato consumption, or lycopene levels, with mixed results. Studies on lycopene supplementation for breast cancer prevention are lacking. More research is needed in this area.

C

Some studies suggest that fruit and vegetable-rich diets may be linked to reduced cancer risk. Although it has not been well studied in humans, early research suggests that lycopene may help prevent a number of different cancers, including bladder cancer and skin cancer. However, the reason behind this potential benefit remains unclear. Studies have also looked at the potential role of tomatoes, tomato-based products, and lycopene levels. However, studies of lycopene supplements are lacking. More research is needed in this area to draw conclusions.

C

Early research has found mixed results for tomato products in reducing the risk of heart disease. More high-quality research is needed before firm conclusions can be made.

C

Research has looked at the possible use of lycopene in preventing cervical cancer. Some studies on tomato intake, lycopene levels, and disease risk suggest benefit with lycopene intake. However, others have found conflicting results. More research is needed before conclusions can be made.

C

Limited research suggests that higher lycopene levels may decrease the risk of plaque build-up in the arteries. These benefits are thought to be due to lycopene's antioxidant effects. However, results from other studies have been conflicting, and most studies used a mixture of ingredients. More information is needed on the potential effects of lycopene alone for this condition.

C

Early research has reported a lack of benefit of lycopene or lycopene-containing foods on type 2 diabetes. More high-quality research is needed in this area.

C

Lycopene has been studied for the prevention of prostate cancer, with mixed results. Early research suggests that lycopene may slow prostate enlargement in people with benign prostatic hypertrophy (BPH). However, more high-quality studies are needed in this area.

C

Lycopene has been suggested to be beneficial for some eye disorders. These include age-related macular degeneration (AMD), which is a breakdown of the retina that may lead to vision loss and cataracts, or clouding of the lens, in the eye. Although some studies suggest that there may be a link between higher lycopene levels and reduced risk of cataracts or AMD, largely the results have been conflicting. More evidence is needed before further conclusions can be made.

C

Early evidence reports that a preparation containing lycopene and other nutrients found in whole tomatoes may help reduce gum disease, bleeding, and plaque. More research is needed to support these findings, especially on the effects of lycopene alone.

C

Early research suggests that lycopene in combination with other treatments may affect heart failure symptoms. Additional research of lycopene alone is needed to draw conclusions.

C

Limited research has shown unclear benefit in using lycopene in addition to standard treatment for H. pylori infection. Additional research is needed before a conclusion may be made.

C

Lycopene has been studied for its potential protective effects on the heart. However, the results are mixed. While some studies report that lycopene may help lower blood pressure, others suggest a lack of benefit or association between lycopene levels and high blood pressure risk. Most of the therapies studied have contained mixed ingredients. More information is needed on the possible effects of lycopene alone.

C

Early research has found inconsistent results for using lycopene to prevent high blood pressure in pregnancy. There were also instances of fetal growth problems in women having their first child after lycopene supplementation. Additionally, most studies looked at mixed-ingredient supplements. High-quality research on lycopene alone is needed.

C

It has been suggested that oxidative damage may negatively affect sperm. Lycopene is believed to have antioxidant benefits and has been studied for use in infertility. Although a link between lycopene levels and semen quality has been suggested, studies have found conflicting results. More research is needed in this area.

C

Early research suggests that lycopene from a mixed ingredient supplement or from fresh tomatoes may lack anti-inflammatory benefits. Results have been inconsistent between studies, many of which have looked at mixed-ingredient therapies. More information is needed on the possible effects of lycopene alone.

C

High-quality studies on the use of lycopene supplementation for kidney disorders or kidney cancer are lacking. Early research suggests that lycopene lacks benefit in kidney cancer. More research is needed to confirm these results.

C

Available research suggests that doses of more than 25 milligrams of lycopene daily may lower levels of low-density lipoprotein (LDL, or "bad") cholesterol and total cholesterol. Although this is promising, more high-quality research is needed in this area.

C

Research suggests that increased lycopene intake may reduce the risk of lung cancer. However, there are also studies suggesting that lycopene lacks benefit for lung cancer. Due to the lack of consistency among studies, a conclusion is unable to be made at this time.

C

Early studies in healthy women suggest that combination lycopene supplementation may reduce some menopausal symptoms. Although this is promising, the effects of lycopene alone are still unknown. More high-quality research is needed in this area.

C

Studies have found benefits of mixed-ingredient lycopene supplementation on mouth sores. However, evidence is limited, and more information is needed on the potential effects of lycopene alone.

C

Research on lycopene alone and in combination with steroid injections suggests benefits for mouth inflammation. More studies on the effects of lycopene alone are needed.

C

Some research suggests that the risk of ovarian cancer may decrease with intake of some antioxidants. However, the benefit of lycopene supplementation is unclear. Research has shown conflicting results of lycopene intake on ovarian cancer risk. More research is needed before conclusions can be made.

C

Early research reports that dietary lycopene intake from tomatoes may be linked to a lower risk of pancreatic cancer. Although this is promising, more studies are needed in this area.

C

Most studies looking at the effects of lycopene on prostate cancer have focused on tomato consumption and have found mixed results. While some research suggests that increased lycopene intake reduces prostate cancer risk, others reported conflicting findings. More information is needed before conclusions can be made.

C

Early research has shown benefits of using lycopene together with saw palmetto and selenium in treating prostate inflammation. Although this is promising, the effects of lycopene alone remain unclear. More high-quality research is needed.

C

The use of lycopene together with other nutrients such as beta-carotene, vitamin C, and vitamin E has been suggested to protect the skin from sun damage. Lycopene-rich tomato paste has also been used for sun protection. Early research suggests benefits, but more research is needed before a firm conclusion may be made.

C

There is inconclusive evidence for lycopene use in preventing cancers of the digestive tract. Limited research reports that cancer risk may decrease with high tomato intake. However, other studies have found either a lack of evidence or conflicting results for stomach and colon cancer. More information is needed to assess the effects of lycopene on these conditions.

C

Limited research found a lack of benefit of lycopene consumption on immune system function. Although information is limited, there is enough evidence to conclude a lack of effectiveness.

D

Exercise may lead to asthma or related lung conditions. Lycopene, which is considered to be an antioxidant, has been studied for its effects on lung function after exercise. Early evidence reported a lack of benefit of lycopene supplementation on lung function. More research is needed to confirm these findings.

D

* Key to grades

A: Strong scientific evidence for this useB: Good scientific evidence for this useC: Unclear scientific evidence for this useD: Fair scientific evidence for this use (it may not work)F: Strong scientific evidence against this use (it likley does not work)

Tradition / Theory
The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.

Many available studies have looked at the effects of mixed-ingredient therapies that contain lycopene. These include Lyc-O-Mato® and LycoRed® (both manufactured by LycoRed Natural Products Industries Ltd., Beer-Sheva, Israel). According to the manufacturer, these two supplements contain lycopene and other nutrients found in whole tomatoes. The effects of lycopene alone are unable to be determined from these studies. However, due to the large amount of information on the use of these mixed-ingredient products, doses that have been used are included in this monograph.

As an antioxidant, 6.5-30 milligrams of lycopene has been taken by mouth once or twice daily from 21 days to four months as Lyc-O-Mato® or LycoRed® capsules. A total of 13.3-30 milligrams of lycopene has been taken by mouth once or twice daily as Lyc-O-Mato® or Lyc-O-Pen® capsules for 1-12 weeks and lacked evidence of benefit.

For asthma caused by exercise, 15-45 milligrams of lycopene in the form of Lyc-O-Mato® or tomato extract and juice has been taken by mouth daily for 1-14 weeks.

For clogged arteries, 4-1,240 milligrams of lycopene has been taken by mouth daily for one week to six months as LycoRed® or Lyc-O-Mato® softules, capsules, or tomato products.

For slowing prostate enlargement, 15 milligrams of lycopene (LycoVit®) has been taken by mouth daily for six months.

For brain tumors, eight milligrams of lycopene has been taken by mouth daily for three months.

For heart disease, lycopene has been taken by mouth in the form of tomato products, capsules, and Lyc-O-Mato® in doses of 39.2-80 milligrams daily for 1-12 weeks. Also, a diet high in tomato-based foods (about 70 milligrams of lycopene weekly) plus a 10 milligram lycopene capsule has been taken by mouth daily for 12 weeks.

For gum disease, 8 milligrams of lycopene as LycoRed® has been taken by mouth daily in divided doses for two weeks. 0.1 milliliters (2 milligrams) of lycopene gel was injected once into an area in the gums.

For H. pylori, 30 milligrams of lycopene has been taken by mouth daily for one month in addition to standard treatment.

For high blood pressure, lycopene has been taken by mouth in 4-44 milligram doses daily for up to six months. Lyc-O-Mato®, containing 15 milligrams of lycopene, has been taken by mouth daily for six weeks and eight weeks. A dose of 250 milligrams of Lyc-O-Mato® has been taken by mouth for eight weeks.

For immune system stimulation, 13.3-15 milligrams of lycopene has been taken by mouth daily for up to 12 weeks as Lyco-O-Pen®, and lacked evidence of benefit.

For infertility, 2 milligrams of lycopene has been taken by mouth twice daily for three months.

For inflammation, 30-40 milligrams of lycopene has been taken by mouth once or twice daily as Lyc-O-Mato® capsules for 1-4 weeks, and lacked evidence of benefit.

For lowering lipid levels, 4-44 milligrams of lycopene has been taken by mouth daily for up to six months as LycoRed® softules or capsules.

For mouth sores, 4-8 milligrams of lycopene (LycoRed®) has been taken by mouth daily in two divided doses for three months.

For inflammation of the mouth, 16 milligrams of lycopene has been taken by mouth daily in two divided doses for two months.

For ovarian cancer prevention, 4 milligrams of lycopene has been taken by mouth daily.

For high blood pressure associated with pregnancy, LycoRed® (containing two milligrams of lycopene per capsule) has been taken once or twice daily until delivery.

For prostate cancer, 2-120 milligrams of lycopene has been taken by mouth once or twice daily for up to one year as Lyc-O-Mato® or LycoRed® softules or capsules.

For protecting the skin from sun damage, 55 grams of tomato paste in olive oil (providing 16 milligrams of lycopene) has been taken by mouth daily for 12 weeks.

Children (younger than 18 years)

There is no proven safe or effective dose for lycopene in children.

Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid in people who are allergic or sensitive to lycopene, tomatoes, or other ingredients in lycopene-containing supplements. Allergic skin reactions and rashes have been reported after lycopene use.

Side Effects and Warnings

There is not enough evidence at this time on the safety of lycopene supplements. However, tomatoes and tomato-based products are common in human diets and lack reported side effects.

Lycopene may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (blood thinners) such as warfarin (Coumadin®) or heparin, antiplatelet drugs such as clopidogrel (Plavix®), and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®).

Lycopene may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba, and fewer cases with garlic and saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.

Lycopene may cause low blood pressure. Caution is advised in people taking herbs or supplements that lower blood pressure.

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.